Status:
COMPLETED
A Study of Safety, Tolerability and Immunogenicity of a 1-Dose Regimen of MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC_HIV Vaccine (V520-019)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is designed to determine whether patients previously primed with Ad5 of MRKAd5 HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with MKRAd5 HIV-1 gag v...
Eligibility Criteria
Inclusion
- Subject was previously enrolled in Merck HIV Vaccine study V520 Protocol 007 or 012, and received the complete 3-dose regimen during participation
- Subject is in good general health
- Subject is not infected with HIV
- Subject agrees not to donate blood during the first 52 weeks of the study
- Subject agrees not to donate sperm during the first 12 weeks of the study
- Subject who is of reproductive potential agrees to use an acceptable method of birth control through Week 12 of the study
Exclusion
- Subject has been administered immune globulin or blood product 3 months prior to receiving study vaccination
- Subject has been vaccinated with a live virus vaccine in the past 30 days
- Subject has been vaccinated with an inactivated vaccine in the past 14 days
- Subject has an active medical disease
- Subject is taking daily required prescription drugs
- Female subject is pregnant, breastfeeding or expecting to conceive
- Subject is positive for HIV
- Subject has used injection drug within the past year
- Subject has a sexual partner that is infected with HIV
- Subject has a sexual partner that is an active injection drug user
- Subject has been treated for or diagnosed with a new sexually transmitted disease in the past 6 months
- Subject engaged in unprotected intercourse with more than 2 persons in the previous 6 months
- Subject engaged in protected intercourse with more than 4 persons in the previous 6 months
- Subject has previously participated in an HIV vaccine clinical trial (other than Merck V520 Protocols 007 and 012)
- Subject weighs less than 110 lbs.
- Subject has a recent history of alcohol abuse
- Subject intends to donate blood in the first 52 weeks of the trial
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00894114
Start Date
May 1 2003
End Date
June 1 2009
Last Update
May 28 2015
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